3D Custom Plate vs. Standard Titanium Plates for Mandibular Sub-condylar Fractures Fixation

Not Applicable

Not yet recruiting

• Conditions: Mandibular Sub-condylar Fracture

• Registration Number: NCT06978530
• Lead Sponsor: Esraa Mosad Tawfik

Brief Summary

This randomized clinical trial aims to conduct a comprehensive clinical and radiographic evaluation by comparing the efficacy of standard titanium fixation plates with three dimensional custom plate in the management of sub-condylar fractures. By assessing the clinical outcomes, accuracy of reduction of the fracture segments, and bite force promoted by both fixation modalities.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-10
• Study First Submitted QC: 2025-05-10
• Study First Posted: 2025-05-18
• Last Update Submitted: 2025-06-02
• Last Update Posted: 2025-06-05
• Study Start: 2025-07-01
• Primary Completion: 2026-04-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Displaced sub condylar fractures, requiring open reduction and rigid internal fixation
• Age ranges from 18 to 60 years
• Fracture duration less than 2 weeks
• Patients with adequate follow up duration for outcome assessment

Exclusion Criteria

• Comminuted sub condylar fractures
• Patients with severe systemic diseases that may affect fracture healing
• Presence of any pathology at the fracture site
• Patients with previous history of mandibular surgery
• Medically compromised patients who are not fit to undergo surgery under general anesthesia
• Patients with in complete medical records or missing follow up data

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Bite force	1 month, 3 months, and 6 months postoperatively	Bite force measured in Newtons at the molar region using a bite force recording device.

Secondary Outcome Measures

Name	Time	Method
Maximum mouth opening	1 month, 3 months, and 6 months postoperatively.	Distance in mm between incisal edges during maximal mouth opening.
Mandibular deviation on opening	1 month, 3 months, and 6 months postoperatively.	Deviation in mm measured using midline reference.
Accuracy of fracture reduction	Immediately postoperative (within 1 week)	Evaluated by comparing preoperative CT with postoperative CT using 3D image superimposition analysis